Acalabrutinib for the Treatment of Relapsed or Refractory Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia
Active, enrolledPhase 2Results postedLast updated 27 April 2025
What this trial tests
Phase 2 trial testing Acalabrutinib in Autoimmune Hemolytic Anemia in 4 participants. Participants enrolled and being followed up; not accepting new ones.
18 and older, any sex, with Autoimmune Hemolytic Anemia or Chronic Lymphocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Autoimmune Hemolytic Anemia (AIHA) - Overall Response Rate (ORR)Primary· Participants were assessed at the end of the 6-week therapy.
ORR is defined as proportion of patients who achieve complete response (CR) and partial response (PR). The probability of having AIHA-ORR at 6 cycles were measured and reported with 95% exact confidence interval (CI). An exact binomial test against a null hypothesis of 30% rate was performed at the 1-sided alpha of 0.05 to determine whether the AIHA-ORR rate at 6 cycles is disappointing or promising.
Group
Value
95% CI
Treatment (Acalabrutinib)
67
9 – 99
Adverse events — posted to ClinicalTrials.gov
Time frame: From the initial study treatment up to 12 months after the end of the treatment, approximately two years..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase II trial studies the effect of acalabrutinib in treating autoimmune hemolytic anemia that has come back (relapsed) or has not responded to previous treatment (refractory) in patients with chronic lymphocytic leukemia. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07257055 — Phase 2 Study of BTKi-Rituximab Induction Followed by Glofitamab Consolidation in High Risk Untreated MCL Patients - WIN
· Phase 2
· recruiting
NCT07377578 — A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cel
· Phase 3
· recruiting
NCT07024706 — Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2
· Phase 2
· not yet recruiting
NCT07283965 — Zanubrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies
· not yet recruiting
NCT07014917 — Intermittent Versus Continuous Venetoclax With Acalabrutinib for CLL/SLL
· Phase 2
· recruiting
Other recruiting trials for Autoimmune Hemolytic Anemia
Currently open trials in the same condition.
NCT07441525 — UCAR-T Targeting CD19/BCMA in Subjects With Autoantibody-Mediated Autoimmune Benign Hematological Diseases
· EARLY_PHASE1
· recruiting
NCT07175493 — A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia
· Phase 1, PHASE2
· recruiting
NCT06921980 — Brain Function and Psychological Changes Related to Cell Therapy for Autoimmune Hemolytic Anemia
· recruiting
NCT06733610 — CAR T-cell Therapy Targeting CD19 and BCMA in Patients with AIHA Who Have Failed ≥3 Lines of Therapy.
· Phase 1
· recruiting
NCT06888960 — Safety Study of CC312 in Autoimmune Disease Patients
· EARLY_PHASE1
· recruiting
Other City of Hope Medical Center trials
Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by City of Hope Medical Center
Last refreshed: 27 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04657094.